The paper deals with the physico-chemical characterization of the solid state of D-mannitol as a first step towards the understanding of the reasons that cause breakage of the vials during lyophilization of pharmaceutical formulations containing mannitol as a bulking agent. alpha and β modifications can be distinguished only by XRPD and FT-IR as they show melting temperature and enthalpy that are the same within the standard deviation. The thermal behaviour of the alpha form (obtained by re-crystallization in acetone) is just a little different and its understanding has required XRPD experiments performed at variable temperature. By cooling the melted sample, under a wide range of experimental conditions, a very fast crystallization occurs and it is such an important heat release that could be at the origin of the vials breakage.
Physico-chemical characterization of anhydrous D-mannitol
BRUNI, GIOVANNA;BERBENNI, VITTORIO;MILANESE, CHIARA;COFRANCESCO, PACIFICO;MARINI, AMEDEO
2009-01-01
Abstract
The paper deals with the physico-chemical characterization of the solid state of D-mannitol as a first step towards the understanding of the reasons that cause breakage of the vials during lyophilization of pharmaceutical formulations containing mannitol as a bulking agent. alpha and β modifications can be distinguished only by XRPD and FT-IR as they show melting temperature and enthalpy that are the same within the standard deviation. The thermal behaviour of the alpha form (obtained by re-crystallization in acetone) is just a little different and its understanding has required XRPD experiments performed at variable temperature. By cooling the melted sample, under a wide range of experimental conditions, a very fast crystallization occurs and it is such an important heat release that could be at the origin of the vials breakage.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
